The following data is part of a premarket notification filed by Serf with the FDA for Ci../..x Liner For Novae Dual Mobility Acetabular Cup.
| Device ID | K142675 |
| 510k Number | K142675 |
| Device Name: | CI../..X Liner For NOVAE Dual Mobility Acetabular Cup |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | SERF 85 AVENUE DES BRUYERES Decines, FR 69150 |
| Contact | Jean-luc Aurelle |
| Correspondent | Catherine Gloster Gloster Biomedical International 577 North Hope Ave Santa Barbara, CA 93110 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-19 |
| Decision Date | 2015-01-15 |
| Summary: | summary |